Mainz Biomed N.V., a molecular genetics diagnostic company, has announced significant topline results from its eAArly DETECT U.S. clinical study. This multi-center feasibility study evaluated the integration of novel gene expression (mRNA) biomarkers into ColoAlert®, the company’s effective and user-friendly screening test for colorectal cancer (CRC), currently available in Europe and select international markets. The eAArly DETECT study demonstrated a remarkable sensitivity for colorectal cancer detection at 97% with a specificity of 97%, and an advanced adenoma sensitivity of 82%.
These results not only confirm but also surpass those from the company’s European ColoFuture Clinical Study, which reported a colorectal cancer sensitivity of 94% and specificity of 97%, with an advanced adenoma sensitivity of 80%. The eAArly DETECT and ColoFuture studies support the inclusion of a portfolio of novel mRNA biomarkers in the upcoming pivotal FDA PMA clinical trial (ReconAAsense), set to begin enrollment in mid-2024.
The eAArly DETECT study enrolled 254 evaluable subjects across 21 sites in the U.S., targeting patients aged 45 and older. The study’s design was similar to that of ColoFuture, involving patients referred for a colonoscopy for various reasons, including CRC screening, follow-up on positive tests, or symptoms, as well as subjects already identified with colorectal cancer but pre-treatment. The study’s outcomes were compared against the results from the ColoAlert® test incorporating the novel biomarkers.
The mRNA biomarkers evaluated in these studies were acquired from the Université de Sherbrooke and are aimed at enhancing ColoAlert®’s technical profile, particularly in identifying advanced adenomas. Early detection of advanced adenomas, which are pre-cancerous, can significantly change the CRC diagnostic landscape, as these are curable at an early stage, preventing the progression to cancer.
Mainz Biomed plans to present the full dataset at an upcoming medical conference and is preparing for the ReconAAsense trial. If successful, this could position the next generation ColoAlert® as a highly robust and accurate at-home CRC diagnostic screening test.